FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
1–24 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 23, 2026
Single-use Flexible Bronchoscope
K261637 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 128d
Cleared Sep 21, 2026
OtoCompanion (Version 1.0)
K261725 · SHL
Ironsides Medical, Inc.
Ear, Nose, Throat · 118d
Cleared Sep 16, 2026
Ambu® aScope™ 5 Broncho 2.7/1.2
K260309 · EOQ
Ambu A/S
Ear, Nose, Throat · 229d
Cleared Sep 15, 2026
CLEARVISION Irrigation Sheath 0° (7241AS)
K254299 · EOB
Karl Storz SE & CO. KG
Ear, Nose, Throat · 258d
Cleared Sep 04, 2026
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM)
K262235 · PGW
Medtronic Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 02, 2026
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U)
K254026 · EOQ
Flexicare Medical Limited.
Ear, Nose, Throat · 260d
Cleared Aug 27, 2026
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
K260401 · PSV
Olympus Medical Systems Corporation
Ear, Nose, Throat · 202d
Cleared Aug 26, 2026
Ponto 5 Mini
K261142 · MAH
Oticon Medical AB
Ear, Nose, Throat · 141d
Cleared Aug 19, 2026
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ...
K253431 · LXB
Shokz Health Global Limited
Ear, Nose, Throat · 322d
Cleared Aug 18, 2026
Tympendi™ (810)
K260266 · KHJ
Grace Medical, Inc.
Ear, Nose, Throat · 202d
Cleared Aug 13, 2026
Levo Gen 2 Tinnitus Therapy System
K260413 · KLW
Levo Medical Corporation
Ear, Nose, Throat · 185d
Cleared Jul 31, 2026
Hearing Aid Feature
K261187 · SCR
Samsung Electronics Co., Ltd.
Ear, Nose, Throat · 112d
Cleared Jul 30, 2026
SeptAlign (SPLN001)
K260620 · NHB
Spirair, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 30, 2026
SMARTVERTIGO™ Vestibular Assessment System
K260566 · GWN
VertigoDx, Inc.
Ear, Nose, Throat · 161d
Cleared Jul 25, 2026
MONARCH™ Platform (MON-000008)
K260382 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 170d
Cleared Jul 22, 2026
Ossiclear (Ossiclear System)
K254296 · LXB
Sounduct
Ear, Nose, Throat · 203d
Cleared Jul 13, 2026
Hearing assist
K254044 · SCR
Meta Platform Technologies, LLC
Ear, Nose, Throat · 208d
Cleared Jul 10, 2026
Cochlear™ Osia® 3(I) Sound Processor
K260902 · PFO
Cochlear Americas
Ear, Nose, Throat · 114d
Cleared Jun 25, 2026
Jabra Enhance Select Self-fit (Jabra Enhance Select 550)
K254108 · QUH
GN Hearing A/S
Ear, Nose, Throat · 188d
Cleared Jun 17, 2026
Hydro Irrigation System
K261544 · EOB
Stryker Instruments
Ear, Nose, Throat · 40d
Cleared Jun 16, 2026
NEUROMARK System (NMK00301)
K261833 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 14d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared Jun 15, 2026
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152,...
K260452 · LXB
Zdeer Technology (Henan) Co., Ltd.
Ear, Nose, Throat · 124d
Cleared Jun 11, 2026
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
K261256 · LXB
Shenzhen Magnet Technology Co., Ltd.
Ear, Nose, Throat · 56d